PRELIM: 3 Flashcards
Derived from Greek word ‘Pharmakon’ meaning _______ and ‘Poiea’ meaning to ______.
drug; make
A legal and official book issued by recognized authorities appointed by the Government of each country.
PHARMACOPOEIA
Published on December 15,
1820, in both Latin and English.
UNITED STATES PHARMACOPOEIA
Essential to gather information on the substance in question, including origin, composition, preparation methods, and potential crystalline forms.
Monographs
(INN) mean
International Nonproprietary Name
Published in 1867, 1898,1914, and 1953.
BRITISH PHARMACOPOEIA
Distinguish clearly between well-defined hydrates and solvates and products with variable quantities of solvent(s).
Hydration and Solvation
It comprises a list of pharmaceutical substances, formulae, descriptions, and standards.
PHARMACOPOEIA
Investigate whether different enantiomers,
racemates, or mixtures of enantiomers are available.
Enantiomer Consideration
The substance described in a monograph is never wholly pure, but contains a limited proportion of impurities.
Impurities
began working in 1964
EUROPEAN PHARMACOPOEIA
quoted are normally confined to water, an alcohol, and a lipophilic solvent; in other solvents may also be mentioned.
Solubility
are specified between which the content must fall, taking into account the precision of the method and acceptable purity.
Assay limits
in BRITISH PHARMACOPOEIA, Volumes I & II contain __________ ___________
medicinal substances
are normally expressed with reference to the dried or anhydrous substance.
Assay Limit
the assay limits are usually 99.0-101.0% (unless otherwise justified).
Non-Specific Assay
the upper assay limit is normally 102.0%, and the lower assay limit takes into account any impurities present.
Specific Assay
with precision to establish the exact graphic formula, empirical formula, and relative molecular mass.
Chemical Structure
Specify each component of the combination or mixture, with its chemical structure and proportion present.
Chemical Combinations
Distinguish clearly between well-defined _____________ ____________ and products with variable quantities of solvent(s).
Hydration and Solvation
For an _________ isomer, specify the absolute configuration.
optical isomer
Specify which is used or state that the product is a mixture of
isomers.
